Study to Evaluate Safety of Vitamin D Receptor Activators in Patients Ages 0 to 16 With Chronic Kidney Disease Stage 5 Receiving Peritoneal Dialysis Within Current Clinical Practice

Stopped early

Conditions studied: Secondary Hyperparathyroidism, End-Stage Renal Disease

In brief

The objective of this study was to observe the safety of paricalcitol utilization in pediatric participants (ages 0 to 16 years old) being treated for secondary hyperparathyroidism (SHPT). Participants were to be followed for a minimum of 3 months and up to approximately 36 months to monitor the incidence of hypercalcemia (high calcium levels in blood).

Key facts

Study ID

NCT01134315

Run by

AbbVie (prior sponsor, Abbott)

People needed

61

Starts

2010-06-01

Expected to finish

2012-05-01

Last updated by the study team

2013-08-13

Who can join

Age: any, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female between 0 to 16 years of age (inclusive), on peritoneal dialysis for at least 30 days.
• The patient has a history of secondary hyperparathyroidism as defined by having initiated a vitamin D receptor activator to treat an elevated parathyroid hormone level.
• The patient is attending a site associated with North America Pediatric Renal Trials and Collaborative Studies (NAPRTCS) Dialysis Registry.
• Patient and the patient's parent or legal guardian must voluntarily sign and date an informed consent and/or assent, approved by the local Independent Ethics Committee/Institutional Review Board, prior to the initiation of any screening or study-specific procedures.
• Patient has received paricalcitol or calcitriol for a minimum of 10 days.

You may not qualify if…

• Patient is scheduled for a kidney transplant within 3 months.
• Patient is expected to stop peritoneal dialysis within 3 months.
• Patient is expected to transfer to hemodialysis within 3 months.
• Patient is planning to be enrolled in an investigational study where the drug and/or dose are unknown to the investigator within the first 3 months from the date of patient enrollment.

Where it is running

• Site Reference ID/Investigator# 37082 — Birmingham, Alabama, United States
• Site Reference ID/Investigator# 26762 — Gainesville, Florida, United States
• Site Reference ID/Investigator# 28529 — Orlando, Florida, United States
• Site Reference ID/Investigator# 26748 — Atlanta, Georgia, United States
• Site Reference ID/Investigator# 37582 — New Orleans, Louisiana, United States
• Site Reference ID/Investigator# 39973 — Baltimore, Maryland, United States
• Site Reference ID/Investigator# 26769 — Boston, Massachusetts, United States
• Site Reference ID/Investigator# 26768 — Detroit, Michigan, United States
• Site Reference ID/Investigator# 26747 — Kansas City, Missouri, United States
• Site Reference ID/Investigator# 26749 — Akron, Ohio, United States
• Site Reference ID/Investigator# 26751 — Cincinnati, Ohio, United States
• Site Reference ID/Investigator# 26765 — Columbus, Ohio, United States
• Site Reference ID/Investigator# 28528 — Oklahoma City, Oklahoma, United States
• Site Reference ID/Investigator# 26763 — Portland, Oregon, United States
• Site Reference ID/Investigator# 28526 — Charlottesville, Virginia, United States
• Site Reference ID/Investigator# 26758 — Seattle, Washington, United States
• Site Reference ID/Investigator# 40382 — Madison, Wisconsin, United States
• Site Reference ID/Investigator# 26759 — Wauwatosa, Wisconsin, United States

Full record on ClinicalTrials.gov

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